177 CONTROLLED, RANDOMIZED MULTICENTER CLINICAL TRIAL OF HIGH-DOSE VERSUS LOW-DOSE BOVINE SURFACTANT VERY PREMATURE INFANTS

摘要

Objective: Comparing high-dose (initial dose 100 mg/kg b.w., HD) with low-dose (initial dose 50 mg/kg b.w.) bovine surfactant given during hour 1 after birth. Patients and methods: Inclusion criteria: GA 24 - 29 weeks, b.w. 500-1500 g, need for intubation and ventilation, absence of congenital malformations and bacterial infections. Retreatment (max. cumulative dose 200 mg/kg b.w.) was permitted if the FiO2 was >0.4. Endpoinf. HD surfactant treatment improves oxygenation (paO2/FiO2) 2 h post treatment compared with LD treatment (sequential analysis, type I and II error 5 % each). Secondary end-points: air leaks, BPD (FiO2 >0.3 or mechanical ventilation at 28 days), IVH (grade II - IV), PDA, ROP (> grade III) and NEC. 41 infants (GA 27.3 weeks, b.w. 991 g) were randomized to HD treatment, 46 infants (GA 27.2 weeks, b.w. 959 g) to LD treatment. Results: Oxygenation was improved significantly in HD compared to LD treatment (paO2/FiO2 181 ± 119.7 versus 228.4 ± 112.3). Further outcome: HD versus LD infants: air leaks 15/33 %, BPD 24/39 %, IVH 24/35 %, PDA 32/37 %, ROP 10/13 %, NEC 0/2 %, death 15/13 %.Conclusion: HD versus LD bovine surfactant treatment in very premature infants significantly improved oxygenation. A tendency towards decreased incidence of pulmonary air-leaks was observed.